NCT01493271

Brief Summary

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

December 14, 2011

Last Update Submit

November 1, 2016

Conditions

Hypertension, Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment

    Day 7

Secondary Outcomes (6)

  • Change in mean daily intraocular pressure (IOP)

    Up to 28 days

  • Change in mean intraocular pressure (IOP) at each assessment time-points

    Up to 28 days

  • Change in intraocular pressure (IOP) during a placebo lead-in phase

    7 days

  • Pharmacokinetics (area under the concentration time curve)

    Day 7

  • Urinary ratio of tetrahydrocortisol to tetrahydrocortisone

    7 days

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

RO5093151

EXPERIMENTAL
Drug: RO5093151

Interventions

PlaceboDRUG

Placebo to RO5093151

Placebo
RO5093151DRUG

oral doses twice daily for up to 28 days

RO5093151

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, at least 21 years of age, inclusive
  • Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
  • Able to participate and willing to give informed consent

You may not qualify if:

  • Presence of extreme narrow angle with complete or partial closure
  • Progressive retinal or optic nerve disease from any cause other than glaucoma
  • History or signs of penetrating ocular trauma
  • Uncontrolled hypertension
  • Clinically significant abnormalities in laboratory test results
  • Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2
  • Kidney disease or dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Morrow, Georgia, 30260, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Sofia, 1517, Bulgaria

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Litomysi, 570 14, Czechia

Location

Unknown Facility

Prague, 100 34, Czechia

Location

Unknown Facility

Ústí nad Labem, 401 13, Czechia

Location

Unknown Facility

Zlín, 762 75, Czechia

Location

Unknown Facility

Budapest, 1115, Hungary

Location

Unknown Facility

Budapest, 1125, Hungary

Location

Unknown Facility

Esztergom, 2500, Hungary

Location

MeSH Terms

Conditions

HypertensionGlaucoma

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOcular HypertensionEye Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 15, 2011

Study Start

December 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(3)BU(1)HU(3)CZ(5)